FDA has proposed guidelines
for approving the first lower-cost copies of biologic drugs derived from
living cells. All that would be required are laboratory and clinical studies
showing the generic versions are "highly similar" to the originals.
This involves what are known as "biosimilar" drugs. They treat
cancer, arthritis and other diseases. Unlike stable generic pharmaceutical
drugs that are often in pills and capsules, biologics are made from biological
material and injected. Companies will have to prove similar protein mapping.
While we applaud any measure to treat a disease more efficiently and economically,
we note that there have been plenty of problems with injuries caused by
generic pharmaceutical drugs, most notably
Reglan (metoclopramide), and we are concerned that this may occur with biologics when approval